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NIH Peer Review in the Population and Social Sciences

NIH Peer Review in the Population and Social Sciences. Center for Scientific Review National Institutes of Health U.S. Department of Health and Human Services. Charles N. Rafferty, Ph.D. Scientific Review Administrator and Referral Officer Center for Scientific Review

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NIH Peer Review in the Population and Social Sciences

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  1. NIH Peer Review in the Population and Social Sciences Center for Scientific Review National Institutes of Health U.S. Department of Health and Human Services

  2. Charles N. Rafferty, Ph.D. • Scientific Review Administrator • and Referral Officer • Center for Scientific Review • National Institutes of Health Study Sections • Health Services Organization and Delivery (HSOD) – reviews R01, R21, and R03 applications • Occupational Health and Safety SBIR/STTR Referral IRGs • HOP, RPHB, BST, and DIG

  3. Outline • Overview of NIH and Peer Review • Application Receipt and Referral • Initial Peer Review Process, The Study Section • Grantsmanship

  4. Premise Understanding the peer review process will help you prepare a successful grant application. Success = Award

  5. Dr. Brent Stanfield • “Our work is critical because we know the result of peer review is the primary factor determining which research NIH funds."

  6. National Institutes of Health • Much of the biomedical research in the United States is supported by the Federal Government, primarily the National Institutes of Health (NIH)

  7. NIH Extramural Awarding Components • National Cancer Institute (NCI) • National Heart, Lung, and Blood Institute (NHLBI) • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) • National Library of Medicine (NLM) • National Institute of Child Health and Human Development (NICHD) • National Institute of Deafness and Other Communication Disorders (NIDCD) • National Institute of Environmental Health Sciences (NIEHS) • National Institute of Neurological Disorders and Stroke (NINDS) • National Institute on Aging (NIA) • National Institute of Allergy and Infectious Diseases (NIAID) • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) • National Institute of Dental and Craniofacial Research (NIDCR) • National Eye Institute (NEI) • National Institute of General Medical Sciences (NIGMS) • National Institute of Mental Health (NIMH) • National Institute for Nursing Research (NINR) • National Institute on Alcohol Abuse and Alcoholism (NIAAA) • National Institute on Drug Abuse (NIDA) • National Center for Complementary and Alternative Medicine (NCCAM) • National Center for Research Resources (NCRR) • National Human Genome Research Institute (NHGRI) • National Institute of Biomedical Imaging and Bioengineering (NIBIB) • Fogarty International Center (FIC) • National Center on Minority Health and Health Disparities (NCMHD)

  8. A Typical Institute/Center National Advisory Council Office of the IC Director Board of Scientific Counselors Extramural Intramural Scientific Programs Laboratory Studies Clinical Studies Grants Contracts

  9. NIH Extramural Program Grant Patron (assistance, encouragement) Cooperative Partner Agreement (assistance but substantial program involvement) Contract Purchaser (procurement)

  10. NIH Funding in FY 2004: By MechanismTotal = $27B Over 80% of NIH funds support extramural research.

  11. NIH Peer Review • Process of evaluation of NIH grant applications for scientific and program merit • NIH uses dual review system • Scientific Review Group or Study Section • Institute/Center Program Review

  12. Dual Review System for Grant Applications • First Level of Review • Scientific Review Group (SRG) • Provides Initial Scientific Merit • Review of Grant Applications • Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review Council • Assesses Quality of SRG • Review of Grant Applications • Makes Recommendation to • Institute Staff on Funding • Evaluates Program Priorities • and Relevance • Advises on Policy

  13. Review Process for a Research Grant National Institutes of Health Research Grant Application School or Other Research Center Center for Scientific Review Assigns to IC & IRG/ Study Section Initiates Research Idea Study Section Submits Application Reviews for Scientific Merit Institute Evaluates for Relevance Advisory Councils and Boards Allocates Funds Conducts Research Recommends Action Institute Director Takes final action

  14. Types of Scientific Review GroupsWhere are Applications Reviewed? GROUPS APPLICATIONS REVIEWED Research Projects CSR IRGs Academic Research Study Sections Enhancement Awards Postdoctoral Fellowships Special Emphasis Panels Small Business Innovation Research Shared Instrumentation INSTITUTES Program Projects Centers Scientific Review Groups Institutional Training Grants Conference Grants Career Awards Small Grants Contract Review Committees RFAs Contracts

  15. Center for Scientific Review (CSR) • Focal Point for Initial Review at NIH • Central receipt point for PHS applications • Referral to Institutes and to IRGs and Study Sections • Review of most research and research training applications ..for scientific merit

  16. Center for Scientific Review • Referral • Central Receipt Point for most PHS Grant Applications • Institute Assignment (Potential Funding Component) • Assignment to Scientific Review Group in CSR or in an Institute • Scientific Review • More than 200 chartered study sections and regularly recurring special emphasis panels that review: • Research Grant Applications • Postdoctoral Fellowship Application • Academic Research Enhancement Award Applications • Small Business Innovation Research Applications

  17. Cycle 2 Receipt Council Review Award Referral Cycle 3 Receipt Council Review Award Referral Overall Timeframe from Submission to Award • There are three overlapping cycles per year : JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL Cycle1 Receipt Review Council Award Referral

  18. Grant Application Receipt and Assignment

  19. Applications Submitted to NIH • Over 60,000 grant applications are submitted to NIH each year, of which 25-30% are funded • Competing grant applications are received for three review cycles per year

  20. CSR Receipt and Referral: Central Receipt Point for Applications submitted to the Public Health Service National Institutes of Health Substance Abuse and Mental Health Services Administration CSR Receipt & Referral Agency for Health Care Policy & Research Centers for Disease Control Office of Assistant Secretary for Health Food & Drug

  21. Applications are Assigned by Referral Officers: Professional scientists, most of whom also serve as scientific review administrators of CSR study sections

  22. Applications are Assigned to: • Scientific review groups based on: • Specific review guidelines for each scientific review group • Institutes based on: • Overall mission of the Institute • Specific programmatic mandates and interests of the Institute

  23. Assignment to Institutes • Applications are referred to an Institute or Center as the potential funding component: • This assignment is based on a match between the research proposed and the overall mission of the Institute or Center • Where applications are appropriate for more than one Institute or Center, multiple assignments are made

  24. Sample Application Number Individual Serial Amended Research Number Grant 1 R01 CA 123456 01 A1 New National Grant Application Cancer Support Institute Year

  25. Special Referral Issues • Investigators should write a cover letter for their applications! • Referral Officers almost always honor investigator requests for Institute assignments (funding) and CSR study section assignments (review) • NIMH, NIAA, and NIDA review all health services and treatment research applications assigned to them for funding • All other investigator-initiated health services and treatment research applications are reviewed by CSR

  26. Initial Review in CSR

  27. CSR Study Sections • Each CSR standing study section has 12-24 members who are primarily from academia • CSR standing study sections convene face-to-face meetings • As many as 60-100 applications are reviewed by each study section • Each study section is managed by a Scientific Review Administrator

  28. Division of Clinical and Population-Based Studies Anita Miller Sostek, Ph.D Behavioral & Biobehavioral Processes IRG (BBBP) Karen Sirocco, Ph.D Endocrinology, Metabolism, Nutrition and Reproductive Sciences IRG (EMNR) Sooja Kim, Ph.D. Brain Disorders and Clinical Neuroscience IRG (BDCN) David Armstrong, Ph.D. Health of the Population IRG (HOP) Robert Weller, Ph.D. Infectious Diseases and Microbiology IRG (IDM) Alex Politis, Ph.D. Risk, Prevention, and Health Behavior IRG (RPHB) Michael Micklin, Ph.D. Surgical Sciences, Biomedical Imaging and Bioengineering IRG (SBIB) Eileen Bradley, D. Sc. Oncological Sciences IRG (ONC) Syed Quadri, Ph.D. CSR Review Divisions Division of Biologic Basis of Disease Elliot Postow, Ph.D. Division of Molecular and Cellular Mechanisms Donald Schneider, Ph.D. Division of Physiology and Pathology Michael Martin, Ph.D. AIDS and Related Research IRG (AARR) Ranga V. Srinivas, Ph.D. Biochemical Sciences IRG (BCS) Zakir Bengali, Ph.D. Cardiovascular Sciences IRG (CVS) Joyce Gibson, D.Sc. Bioengineering Sciences and Technologies IRG (BST) Sally Amero, Ph.D. Digestive Sciences IRG (DIG) Mushtaq Khan, Ph.D. Biology of Development and and Aging IRG (BDA) Sherry Dupere, Ph.D. Hematology IRG (HEME) Joyce Gibson, D.Sc. Immunology IRG (IMM) Calbert Laing, Ph.D. Biophysical and Chemical Sciences IRG (BPC) John Bowers, Ph.D. Integrative, Functional and Cognitive Neuroscience IRG (IFCN) Christine Melchior, Ph.D. Cell Development and Function IRG (CDF) Marcia Steinberg, Ph.D. Musculoskeletal, Oral, and Skin Sciences IRG (MOSS) Daniel McDonald, Ph.D. Genetic Sciences IRG (GNS) Richard Panniers, Ph.D. Renal and Urological Sciences IRG (RUS) Daniel McDonald, Ph.D. Molecular, Cellular and Developmental Neuroscience IRG (MDCN) Carole Jelsema, Ph.D. Respiratory Sciences IRG (RES) Mushtaq Khan, Ph.D.

  29. Biobehavioral and Behavioral Processes IRG (BBBP) Study Sections • BRLE – Biobehavioral Regulation, Learning and Ethology • MESH – Biobehavioral Mechanisms of Emotion, Stress and Health • LCOM – Language and Communication • CP – Cognition and Perception • APDA – Adult Psychopathology and Disorders of Aging • CPDD – Child Psychopathology and Developmental Disabilities • MFSR – Motor Function, Speech, and Rehabilitation • BBBP Small Business Activities

  30. Health of the Population IRG (HOP) Study Sections • CLHP – Community-Level Health Promotion • BGES – Behavioral Genetics and Epidemiology • SSPS - Social Sciences and Population Studies • HSOD – Health Services Organization and Delivery • BMRD - Biostatistical Methods and Research • ECD - Epidemiology of Chronic Disease • EPIC – Epidemiology of Cancer • ECDA – Epidemiology of Clinical Disorders and Aging • NSCF – Nursing Science: Children and Families • NSAA – Nursing Science: Adults and Older Adults • HOP Small Business Activities

  31. Risk Prevention and Health Behavior IRG (RPHB) Study Sections • PDRP – Psychosocial Development, Risk and Prevention • PRDP – Psychosocial Risk and Disease Prevention • BMIO – Behavioral Medicine Interventions and Outcomes • SPIP - Social Psychology, Personality and Interpersonal Processes • RPHB Small Business Activities

  32. Scientific Review Administrator • Designated Federal Official • Performs administrative and technical review of applications • Selects reviewers • Manages study sections • Prepares summary statements • Provides requested information about study section recommendations to Institutes and National Advisory Councils/Boards

  33. Selection of Peer Reviewers Active and Productive Researchers Research Capability Non-Research Non-Doctoral Scientific Community

  34. Criteria For Selection of Peer Reviewers • Demonstrated Scientific Expertise • Doctoral Degree or Equivalent • Mature Judgment • Work Effectively in a Group Context • Breadth of Perspective • Impartiality • Interest in Serving • Adequate Representation of Women and Minority Scientists

  35. Review of Research Grants REVIEW CRITERIA: • Significance • Approach • Innovation • Investigator • Environment _________ • Protection of Human Subjects • Inclusion of Women, Minorities, and Children • Animal Welfare/Biohazards • Overall Evaluation & Score Reflects Impact on Field

  36. Review Criteria (continued) • Significance: Does the study address an important problem? How will scientific knowledge be advanced? What are the societal benefits? • Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? • Innovation: Are there novel concepts or approaches? Are the aims original and innovative? • Investigator: Is the investigator appropriately trained? • Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

  37. Additional Review Criteria – Amended Applications (Most Mechanisms) • Adequacy of response to the previous review • Degree of overall improvement of the revised application

  38. Scientific Review Group or Study Section Actions • Scored, Scientific Merit Rating (priority scores and percentiles) • Unscored (lower half) • Deferral • Not recommended for further consideration

  39. Priority Scores/Percentile Rank • For each study section, applications in the upper half are scored from 1.0-3.0, with 1.0 the best score • Individual scores are averaged and multiplied by 100 to give the final priority score • Percentile ranking is calculated based on results of current • plus past two meetings

  40. Summary Statement • Once applications are reviewed, the results are documented by the SRA in a summary statement and forwarded to the Institute (and the PI) where a funding decision is made: • The summary statement contains: • Overall Resume and Summary of Review Discussion • Essentially Unedited Critiques • Priority Score and Percentile Ranking • Budget Recommendations • Administrative Notes

  41. What Determines Which Awards Are Made? • Scientific merit • Program considerations • Availability of funds

  42. Grantsmanship Steps in preparing a successful grant application

  43. There is no grantsmanship that will turn a bad idea into a good one, but……..There are many ways to disguise a good one. William Raub, Past Deputy Director, NIH

  44. The NIH Grant Culture • Bio-Medical Model • Randomized Clinical Trial as gold standard • Evidence based • Underlying Conceptual Model • Emphasis on Outcomes • Need for Measurement

  45. Step One – Scoping • Identify possible research projects • Use web-based NIH data-bases and resources • Identify candidate NIH Institutes/Centers • Identify candidate NIH grant initiatives • Program announcement (PA) • Request for applications (RFA) • Investigator initiated application • Review NIH grant application procedures – PHS 398 Instructions

  46. Step Two – Make NIH Contacts • Confer with NIH Program Directors • Assess the “fit” to the Institute/Center • Find out what’s new – PAs and RFAs • Decide on mechanism – e.g., RO1, R03, R21 • Find collaborators • Identify review issues – Dos and Don’ts • Define product and focus application

  47. Types of Grants • R01 – Research Projects • R03 – Small Research Grants • R21 – Exploratory/Developmental Grants • R13 –Conference Grants • R41/R42 – Small Business Technology Transfer Grants Phase I/II • K-Awards – Career Development • F-Awards - Fellowships • P01 – Research Program Projects http://deainfo.nci.nih.gov/flash/awards.htm

  48. NIH Grant Mechanisms • R01 Traditional investigator-initiated grant < $500K/yr, 3-5 yrs. Need approval if more than $500K for any year of the grant • R03 Small Grant < $100K for 2 yrs • R21 (NCI) Exploratory/Developmental Grant < $275K for 2 yrs • R13Conference Grants amount dependent on score, timeliness, budget, NIH interest

  49. NIH Opportunities for Young Investigators • National Research Service Individual Fellowship (F32) • Mentored Research Scientist Development Award (K01) • Independent Scientist Award (K02) • Mentored Clinical Scientist Development Award (K08) • Small Grant (R03) • Academic Research Enhancement Award (R15) • Exploratory/Developmental Grant (R21)

  50. Step 3 Develop Your Idea • Review literature • Generate preliminary data • Enlist collaborators, include letters of commitment • Review successful grant applications of other colleagues

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